With increasingly novel drug development programs, meaningful collection of subject samples has never been more relevant. Don’t let potential analyte instability mislead your program as it gets underway, causing costly time delays. Sample integrity knowledge will assist you to ask relevant questions of your potential clinical sites and better understand your bioanalytical needs. In this webinar, we will discuss some of the issues related to subject sample collection to ensure reliable data for your drug program.
With over 40 years of experience, Dr.Gene is an accomplished scientist with expertise that spans drug development and a solid understanding of regulatory requirements in bringing new drugs to market. He has extensive knowledge and experience in the raw material characterization; GMP drug formulation analyses; bioanalytical method development; bioanalytical GLP method validation and sample analyses for a wide range drug moieties and their metabolites; mass balance investigations; establishment of numerous biomarker assays; pharmacokinetic analysis and interpretation; protocol design and peer review.
During his 10 years at MRI, he was responsible for drug characterization and assay development under grants from the National Cancer Institute (NCI) for their anti-neoplastic and anti-viral compounds.
Gene holds a doctorate degree in Pharmaceutical Chemistry from the University of Missouri – Kansas City. During his 29 years at KCAS, he gained a wealth of expertise, developing and validating a wide range of bioanalytical method, including challenging tissue assays. His responsibilities included R&D, study conduct as Principal Investigator, and Senior Scientific Advisor. He has also served as the board member with WCG IRB for 12 years, during which he reviewed over 270 clinical studies, primarily for first in human trials.
Dr.Jason Geue has 15 years of experience in the field of bioanalysis. Jason and his team at Agilex Biolabs are responsible for developing robust mass spectrometry assays in a variety of matrices under GLP regulations, to support preclinical and clinical release studies.
With a PhD in chemistry and a Bachelor of Science with Honours in chemistry, Jason currently has 10 peer-reviewed scientific papers in high impact journals. He has a background in bioanalysis in research and industry roles and specialised expertise in complex method development and mass spectrometry analysis.
Jason has a passion for problem solving and enjoys the challenge of successfully troubleshooting analytical problems to find solutions to commercial and scientific challenges for each client.
Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.